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Transcatheter Mitral Valve Repair

SAPIEN M3 System for Mitral Regurgitation (SAPIEN M3 EFS Trial)

N/A
Waitlist Available
Research Sponsored by Edwards Lifesciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
18 years of age or older
High risk of cardiovascular surgery
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days
Awards & highlights

SAPIEN M3 EFS Trial Summary

This trial will study whether it is safe to implant the SAPIEN M3 System in patients with severe MR, and will also provide information to help plan future clinical studies using this system.

Who is the study for?
This trial is for adults with severe mitral valve regurgitation who are at high risk for heart surgery, stable on heart failure meds, and not pregnant. They must understand the study and consent to it. Excluded are those with other valve issues, mechanical aortic valves, history of certain cardiovascular events or procedures within specified time frames, participation in another study, refusal of blood products, specific cardiac conditions that could interfere with treatment effectiveness or safety.Check my eligibility
What is being tested?
The Edwards SAPIEN M3 System is being tested to see if it's safe and works well for treating severe symptomatic mitral regurgitation (MR). The trial will help design future studies by collecting initial data on this new medical device's performance.See study design
What are the potential side effects?
While the side effects aren't listed here specifically for the SAPIEN M3 System, similar interventions may include complications like bleeding at the catheter site, infection risks from invasive procedures, potential damage to nearby heart structures during implantation.

SAPIEN M3 EFS Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I am at high risk for heart surgery.

SAPIEN M3 EFS Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at the end of the procedure
This trial's timeline: 3 weeks for screening, Varies for treatment, and at the end of the procedure for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Technical Success
Secondary outcome measures
Reduction in mitral regurgitation (MR)

SAPIEN M3 EFS Trial Design

1Treatment groups
Experimental Treatment
Group I: TMVRExperimental Treatment1 Intervention
Subjects will undergo transcatheter mitral valve replacement

Find a Location

Who is running the clinical trial?

Edwards LifesciencesLead Sponsor
180 Previous Clinical Trials
61,500 Total Patients Enrolled

Media Library

Edwards SAPIEN M3 System (Transcatheter Mitral Valve Repair) Clinical Trial Eligibility Overview. Trial Name: NCT03230747 — N/A
Mitral Valve Regurgitation Research Study Groups: TMVR
Mitral Valve Regurgitation Clinical Trial 2023: Edwards SAPIEN M3 System Highlights & Side Effects. Trial Name: NCT03230747 — N/A
Edwards SAPIEN M3 System (Transcatheter Mitral Valve Repair) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03230747 — N/A
Mitral Valve Regurgitation Patient Testimony for trial: Trial Name: NCT03230747 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research endeavor currently taking on new participants?

"As indicated on clinicaltrials.gov, the enrolment period for this trial has ended as of June 15th 2022. Originally posted on September 14th 2017, no further participants are needed at present time; however there exists 99 other trials with open recruitment periods."

Answered by AI

Are there multiple healthcare facilities currently executing this test?

"Sentara Cardiovascular Research Institution in Norfolk, Virginia, Cedars-Sinai Medical Center Heart Institute in Los Angeles, California and Evanston/ Northshore University in Illinois are three of the ten total centres that are currently enrolling participants for this trial."

Answered by AI

Who else is applying?

What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

I WAS AT CLEVELAND CLINIC , I HAVE SEVERE MITRAL REGURATION THEY SAID THE TRIAL HAVE BEEN POSTPONED.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
SAPIEN M3 EFS: Early Feasibility Study of the Edwards SAPIEN M3 System for the Treatment of Mitral Regurgitation
2017. "SAPIEN M3 EFS: Early Feasibility Study of the Edwards SAPIEN M3 System for the Treatment of Mitral Regurgitation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03230747.
~10 spots leftby Apr 2025
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